Treatment for Shingles

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Shingles
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial will assess the long-term efficacy, immunogenicity, and safety of the herpes zoster subunit vaccine in older adults.

Eligible Conditions
  • Shingles

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Similar Trials

1
Fixed Dose-Ranging
1
Valacyclovir
1
ZVL >5 years previously

Study Objectives

0 Primary · 6 Secondary · Reporting Duration: From 1-month post-Dose 2 in the ZOSTER-006/022 studies until the end of the ZOSTER-101 study at Month 48

Month 12
Anti-glycoprotein E (gE) antibody concentrations
Frequency of gE-specific Cluster of Differentiation (CD)4+ T-cells secreting at least two activation markers from among IFN-γ, IL-2, TNF-α, CD40L
Month 48
Percentage of participants with HZ-related complications of confirmed HZ
Percentage of participants with potential immune-mediated diseases (pIMDs) (serious and non-serious) causally related to the study intervention
Percentage of participants with serious adverse events (SAEs) causally related to the study intervention
Month 48
Number of participants in LTFU and Control groups with confirmed HZ cases

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Similar Trials

1
Fixed Dose-Ranging
1
Valacyclovir
1
ZVL >5 years previously

Trial Design

0 Treatment Group

3662 Total Participants · 0 Treatment Group

Primary Treatment: Treatment · No Placebo Group · Phase 3

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from 1-month post-dose 2 in the zoster-006/022 studies until the end of the zoster-101 study at month 48

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,648 Previous Clinical Trials
7,941,325 Total Patients Enrolled
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,560 Previous Clinical Trials
6,124,788 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

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References

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